Skip to content

Active ingredient

Albuterol

130 finished FDA listings contain Albuterol as their only active ingredient; 19 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
ALBUTEROL, ALBUTEROL SULFATE
Dosage forms
Aerosol, Metered, Inhalant, Powder, Metered, Solution, Syrup, Tablet
Routes
Oral, Respiratory (Inhalation)
Manufacturers / labelers
46
Strengths listed
.63 mg/3ml · .83 mg/ml · 1.25 mg/3ml · 108 ug/1 · 2 mg/1 · 2 mg/5ml · 2.5 mg/.5ml · 2.5 mg/3ml · 4 mg/1 · 90 ug/1
Brand names in FDA listings
Albuterol, Albuterol Sulate Hfa, Albuterol Sulfate Hfa, Albuterol Sulfate Inhalation, Albuterol Sulfate Inhalation Solution, Albuterol Sulfate Inhalation Solution, 0.5%, Proair Digihaler, Proair Respiclick, Ventolin Hfa

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 435

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 072637SUN PHARM INDUSTRIES1989-02-015
ANDA 072151CHARTWELL RX1989-03-232
NDA 020503KINDEVA1996-08-154
ANDA 074880NEPHRON1997-09-1712
NDA 020983GLAXOSMITHKLINE2001-04-1914
ANDA 075664NEPHRON2001-06-263
ANDA 076355NEPHRON2004-06-286
NDA 021457TEVA BRANDED PHARM2004-10-294
ANDA 077788CHARTWELL RX2007-06-262
ANDA 077839RITEDOSE CORP2008-12-169
NDA 205636TEVA BRANDED PHARM2015-03-312
ANDA 207857SUN PHARM2017-07-214
ANDA 206224LUOXIN AUROVITAS2017-10-173
ANDA 208804AMNEAL PHARMS CO2018-05-212
ANDA 207046RISING2018-06-295
ANDA 212197QUAGEN2019-09-064
ANDA 203760PADAGIS US2020-02-244
ANDA 209959CIPLA2020-04-086
ANDA 211888LUOXIN AUROVITAS2020-04-204
ANDA 213657AUROBINDO PHARMA LTD2020-05-142
ANDA 209954LUPIN2020-08-249
ANDA 208884ZYDUS PHARMS2020-10-224
ANDA 207085SANDOZ2021-06-017
ANDA 214531RITEDOSE CORP2021-12-284
ANDA 215571LEXENPHARM2024-05-032
ANDA 212447ARMSTRONG PHARMS2024-05-214
ANDA 218386RITEDOSE CORP2025-03-121
ANDA 211600AMNEAL IRELAND LTD2025-12-011
ANDA 219409CIPLA2026-04-221

Official labeling on DailyMed

Showing the 12 most recent of 103 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.